[Letter to Shareholders – Notice Regarding Bonus Issue of Shares]

Dear Shareholders,

 

On Monday, May 26, Celltrion announced its plan to conduct a bonus issue of shares aimed at enhancing shareholder value. We would like to provide the following information regarding this matter:

 

 

■ Key Details of the Bonus Issue

 

The company has resolved to issue 0.04 new common shares for each existing share. The scheduled listing date for the new shares is July 25, 2025, and the record date (closure of shareholder registry) is June 10, 2025. The total number of new shares to be issued is 8,494,384. This issuance amount has been determined by taking into account the number of treasury shares previously repurchased by the company, thereby minimizing the burden on circulating shares.

 

Compared to the cancellation of treasury shares, a bonus issue allows for the sharing of potential value gains with shareholders when the new shares are listed. As noted, the new shares are scheduled to be listed on July 25, and around that time, the company plans to announce its Q2 provisional earnings. Through this bonus issue, shareholders can expect an approximately 4% stock dividend effect.

 

This decision was made in light of recent excessive undervaluation of our stock price due to external supply factors—such as the resumption of short selling and tariff-related issues—despite fundamental improvements in the company. It reflects our confidence in the company’s value and our commitment to responsible shareholder value enhancement.

 

 

■ Ongoing Commitment to Responsible Management and Shareholder Value Enhancement

 

The company is continuing its responsible management practices to stabilize the stock price and encourage long-term investment. This includes activities such as share buybacks and cancellations, CEO stock purchases, and the "Value-Up Program" announced in March.

 

With continued annual revenue growth exceeding 30%, this year we anticipate more than 40% growth year-over-year, driven by the launch of four high-margin biosimilar products.

 

However, despite these fundamental strengths, the stock remains significantly undervalued due to external factors like the resumption of short selling and tariff issues. This bonus issue aims to restore market confidence and enhance shareholder value.

 

Going forward, we will actively respond to market distortions and work toward mid- to long-term performance improvement. We also remain committed to our principle of returning at least 30% of EBITDA-CAPEX (earnings before interest, tax, depreciation, and amortization minus capital expenditures) to shareholders as part of our responsible management policy.

 

 

We sincerely appreciate your continued trust and support in Celltrion.

 

Thank you.

 

 

 

※ Tax Information Regarding the Bonus Issue

 

This bonus issue will be conducted using tax-exempt capital, so the newly issued shares themselves will not be taxed as dividend income. However, since treasury shares are excluded from the allocation, all shareholders will see an increase in ownership ratio post-issue, which may be subject to deemed dividend taxation under the relevant tax laws.

 

For shareholders holding fewer than 3,945 shares before the bonus issue, the deemed dividend from the ownership ratio increase is estimated to fall below the minimum tax threshold (KRW 1,000), and therefore will not be subject to separate income tax. However, if total financial income (including dividends and interest) exceeds KRW 20 million in 2025, the deemed dividend from this bonus issue will be added to the total taxable amount and may incur additional tax. (No additional tax applies if total financial income is below KRW 20 million.)

 

 

※ Celltrion resolved to conduct a stock bonus issue through a board resolution on May 26, 2025. In accordance with Article 176-2, Paragraph 2, Subparagraph 3 of the Enforcement Decree of the Financial Investment Services and Capital Markets Act, the company will not acquire any treasury shares between the date of the board resolution and the record date for the allocation of new shares (June 10, 2025). Accordingly, reflecting changes in the treasury stock acquisition plan, the number of new shares to be issued as previously disclosed on May 26 has been corrected from 8,477,626 shares to 8,494,384 shares (as disclosed on May 28).
 

Read more
[Notice] Celltrion Online Conference Video Now Available

We are pleased to share the link of the English-subtitled video clip of the <Celltrion Online Conference>, held on Thursday, May 15, 2025 for international viewers.


Thank you.

▶ Click here to watch the conference video ◀

Read more

Daring to Go Beyond

One-Stop
Solution
Provider

Celltrion provides one-stop solutions for the entire process of biopharmaceutical business from R&D to clinical trials, regulatory affairs, production and distribution.

Read more

Advanced and affordable,
globally accessible

We established a global distribution network
in over 100 countries
including the US, Europe and more.

Read more

News

Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths

YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar[1]Celltrion previously received interchangeability (IC) designation for YUFLYMA® (adalimumab-aaty) in prefilled syringes (20mg & 80mg); Expanded interchangeability (IC) designation applies to prefilled syringe (40mg) and autoinjectors (40mg and 80mg)  INCHEON, South Korea, May 23, 2025 /-- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted an expanded interchangeable designation for YUFLYMA® (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations. With this approval, YUFLYMA is now fully interchangeable with the reference product, Humira® (adalimumab), across all marketed dosage forms and strengths. YUFLYMA is a high-concentration, citrate-free biosimilar to Humira, approved for multiple inflammatory indications including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), ulcerative colitis (UC), plaque psoriasis (Ps), hidradenitis suppurativa (HS), and uveitis (UV) in adult patients; Crohn's disease (CD) in adults and pediatric patients 6 years of age and older; and juvenile idiopathic arthritis (JIA) in patients 2 years of age and older.[1]  "This full interchangeability designation comes at a pivotal time as Celltrion continues to lead in the evolving biosimilar landscape," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “YUFLYMA – a high-concentration, citrate-free adalimumab biosimilar now fully interchangeable with Humira – reflects our long-standing commitment to delivering high-quality, accessible treatment options. Going forward, Celltrion will continue to put patients first by keeping drug costs affordable and remaining at the forefront of the U.S. biosimilar market, bringing competitive pricing and high-quality, accessible treatment options.” The interchangeable designation builds on the Phase III interchangeability study, which demonstrated similar outcomes in terms of pharmacokinetics, efficacy, safety and immunogenicity in patients with moderately to severely active plaque psoriasis who received reference adalimumab (ADA) continuously and those who alternated between reference ADA and YUFLYMA during the dosing interval of Weeks 25-27. The result of the interchangeability study was presented at the European Academy of Dermatology & Venereology (EADV), September 2024, in the Netherlands.[2] YUFLYMA was first introduced in the U.S. market in July 2023 and is currently available as a 20mg, 40mg, and 80mg solution for injection in prefilled syringes and as 40mg and 80mg in autoinjectors. Celltrion offers adalimumab-aaty in both branded and unbranded versions, with two pricing options to meet different patient needs and improve patient affordability.  Notes to Editors: About YUFLYMA® (CT-P17, biosimilar adalimumab-aaty)[1] YUFLYMA is a high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval. YUFLYMA is FDA approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. YUFLYMA has been designated by the FDA as an interchangeable biosimilar in a prefilled syringe and autoinjector. YUFLYMA is a recombinant fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody. YUFLYMA is available in prefilled syringe as 20mg/0.2mL, 40mg/0.4mL and 80mg/0.8mL and autoinjector as 40mg/0.4mL and 80mg/0.8mL. Additionally, YUFLYMA features one of the longest shelf lives in its class, maintaining stability at room temperature (77 °F, 25 °C) for up to 31 days. IMPORTANT SAFETY INFORMATION[1]This important safety information also applies to YUFLYMA® (adalimumab-aaty). SERIOUS INFECTIONS Patients treated with adalimumab-aaty are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before adalimumab-aaty use and during therapy. Initiate treatment for latent TB prior to adalimumab-aaty use.Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with adalimumab-aaty prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with adalimumab-aaty, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Treatment with adalimumab-aaty should not be initiated in patients with an active infection, including localized infections.Patients over 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with adalimumab-aaty, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy.Drug interactions with biologic products: In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of adalimumab-aaty with abatacept or anakinra is not recommended in patients with RA. A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of adalimumab-aaty and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS. Concomitant administration of adalimumab-aaty with other biologic disease-modifying antirheumatic drugs (DMARDs) (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to the use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. Consider the risks and benefits of TNF blocker treatment including adalimumab-aaty prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC), or when considering continuing a TNF blocker in patients who develop a malignancy.In controlled portions of clinical trials of some adalimumab products, more cases of malignancies have been observed compared to control-treated adult patients.NMSC was reported during clinical trials for patients treated with adalimumab products. During the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, PS, HS and UV, the rate (95% confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100 patient-years among adalimumab-treated patients and 0.2 (0.10, 0.59) per 100 patient-years among control-treated patients. Examine all patients, particularly those with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of psoralen + ultraviolet light A (PUVA) treatment, for the presence of NMSC prior to and during treatment with adalimumab-aaty.In clinical trials of some adalimumab products, there was an approximately threefold higher rate of lymphoma than expected in the general U.S. population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to severalfold) than the general population for the development of lymphoma, even in the absence of TNF blockers.Postmarketing cases of acute and chronic leukemia were reported with the use of a TNF blocker in RA and other indications. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving adalimumab were lymphomas; other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. HYPERSENSITIVITY Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of adalimumab-aaty and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including adalimumab-aaty, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV and closely monitor such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy.In patients who develop HBV reactivation, stop adalimumab-aaty and initiate effective antiviral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of adalimumab-aaty therapy in this situation and monitor patients closely. NEUROLOGIC REACTIONS Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.Exercise caution in considering the use of adalimumab-aaty in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of adalimumab-aaty should be considered if any of these disorders develop.There is a known association between intermediate uveitis and central demyelinating disorders. HEMATOLOGIC REACTIONS Rare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents.Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with adalimumab products.Consider discontinuation of adalimumab-aaty therapy in patients with confirmed significant hematologic abnormalities. HEART FAILURE Cases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products.Exercise caution when using adalimumab-aaty in patients who have heart failure and monitor them carefully. AUTOIMMUNITY Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with adalimumab-aaty, discontinue treatment. IMMUNIZATIONS Patients on adalimumab-aaty may receive concurrent vaccinations, except for live vaccines.It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating adalimumab-aaty therapy.No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products.The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. ADVERSE REACTIONS The most common adverse reactions in adalimumab clinical trials (>10%) were infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. INDICATIONS Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RAJuvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and olderPsoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsAAnkylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active ASCrohn's Disease (CD): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and olderUlcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockersPlaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriateHidradenitis Suppurativa (HS): treatment of adult patients with moderate to severe hidradenitis suppurativaUveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients For Yuflyma (adalimumab-aaty): Please click for Full U.S. Prescribing Information. For adalimumab-aaty: Please see Full U.S. Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About Celltrion, Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us  and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo) and OMLYCLO® (omalizumab-igec), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on LinkedIn. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", "anticipate" the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. Trademarks Humira is a registered trademark of AbbVie.YUFLYMA® is a registered trademark of Celltrion, Inc., used under license. References[1] YUFLYMA US prescribing information (2023)[2] Lebwohl M et al., Pharmacokinetics, Efficacy and Safety after Multiple Switches from Reference Adalimumab to Adalimumab Biosimilar (CT-P17) in comparison with the Maintenance Group (Reference Adalimumab) in Patients with Moderate-toSevere Plaque Psoriasis: Week 27 Results from the Phase III Interchangeability Study. [EADV 2024, Poster number P0931]. Available at:https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.eadv/abstracts_congress_2024/41489.pdf

2025
05
23
Celltrion to present six abstracts in inflammatory bowel disease (IBD) at 2025 Digestive Disease Week® (DDW)

Six abstracts accepted for presentation includes post hoc analyses and real-world evidence for ZYMFENTRA® (infliximab-dyyb)Findings reinforce clinical decision-making in long-term management of moderate-to-severe Crohn's disease and ulcerative colitis and underscore Celltrion's commitment to advancing scientific understanding in the field of IBD INCHEON, South Korea, April 28, 2025 -- Celltrion, Inc. today announced that six abstracts will be presented at the 2025 Digestive Disease Week® (DDW) Annual Meeting, taking place May 3-6 in San Diego, California. The oral and poster presentations will feature data including post hoc analyses of its pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) of ZYMFENTRA®, the first and only FDA-approved subcutaneous infliximab. "We are excited by the opportunity to present further analyses reinforcing ZYMFENTRA's clinical value for HCPs and patients," said Hetal Patel, PharmD MBA, Vice President of Medical Affairs at Celltrion USA. "With IBD management becoming increasingly individualized, we anticipate these analyses will help clarify how ZYMFENTRA performs across a wide range of patient types, from long-term drug persistence to recapture following dose escalation." The presentations reflect Celltrion's continued commitment to making comprehensive clinical and real-world evidence accessible to healthcare professionals in the U.S., supporting informed treatment decisions in a complex and evolving IBD landscape. The details of Celltrion's abstract presentations are as follows:Abstract TitlePresentation DetailsAll times PDTEndoscopic and histologic outcomes in patientswith moderate-to-severe ulcerative colitis treatedwith subcutaneous infliximab: A post hoc analysisof the LIBERTY-UC study Poster Presentation #0035IMIBD_POS: IBD: Controlled Clinical Trials in HumansSunday May 4, 2025 / 12:30-13:30 Time to clinical recapture after dose escalation ofsubcutaneous infliximab following loss ofresponse: A post hoc analysis of the 2-year Phase3 LIBERTY-CD & LIBERTY-UC trials Poster Presentation #0016IMIBD_POS: IBD: Controlled Clinical Trials in HumansSunday May 4, 2025 / 12:30-13:30 Efficacy of subcutaneous infliximab maintenancetherapy according to disease location in patientswith moderate-to-severe Crohn's disease: A posthoc analysis of the Phase 3 LIBERTY-CD study Poster Presentation #0039IMIBD_POS: IBD: Controlled Clinical Trials in HumansSunday May 4, 2025 / 12:30-13:30 Impact of immunogenicity on 2-year clinicaloutcomes in patients with moderate-to-severeCrohn's disease treated with subcutaneousinfliximab: A post hoc analysis of the Phase 3LIBERTY-CD study Poster Presentation #0011IMIBD_POS: IBD: Controlled Clinical Trials in HumansSunday May 4, 2025 / 12:30-13:30 Characterization of patients who experience lossof response during maintenance treatment withsubcutaneous infliximab: A post hoc analysis ofthe 2-year Phase 3 LIBERTY-CD & LIBERTY-UCtrials Poster Presentation #0017IMIBD_POS: IBD: Controlled Clinical Trials in HumansSunday May 4, 2025 / 12:30-13:30 Nationwide population-based cohort study on theuse and persistence of infliximab IV and SC inFrance: Riposte IBD study Poster Presentation #0014IMIBD_POS: IBD: Comparative Effectiveness StudiesTuesday May 6, 2025 / 12:30-13:30 Notes to Editors: About ZYMFENTRA® (infliximab-dyyb) ZYMFENTRA® (infliximab-dyyb) is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of moderately-to-severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV), Moderately-to-severely active Crohn's disease following treatment with an infliximab product given by intravenous infusion (IV). ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body. ZYMFENTRA was approved by the FDA through the Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a "stand-alone" BLA). ZYMFENTRA is considered a new biologic with a first-approved subcutaneous administration form and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040. Indication and Important Safety Information ZYMFENTRA® is a prescription medicine indicated in adults for maintenance treatment of: Moderately-to-severely active Crohn's disease following treatment with an infliximab product administered intravenously. Moderately-to-severely active ulcerative colitis following treatment with an infliximab product administered intravenously. It is not known if ZYMFENTRA is safe and effective in children under 18 years of age. What is the most important information I should know about ZYMFENTRA? SERIOUS INFECTIONS Patients treated with ZYMFENTRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis.Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with ZYMFENTRA. Treatment for latent infection should be initiated prior to treatment with ZYMFENTRA. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with ZYMFENTRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with ZYMFENTRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.Risk of infection may be higher in patients greater than 65 years of age, patients with comorbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab included arthritis bacterial, pneumonia, and urinary tract infection. MALIGNANCIES Malignancies, some fatal, have been reported in children, adolescents, and young adults treated with TNF blockers, including infliximab products. Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants. Post-marketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn's disease or ulcerative colitis, and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with ZYMFENTRA, especially in these patient types. In clinical trials of all TNF blockers, more cases of malignancies were observed compared with controls and the expected rate in the general population. In clinical trials of some TNF blockers, including infliximab products, more cases of other malignancies were observed compared with controls. As the potential role of TNF blocker therapy in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. CONTRAINDICATIONS ZYMFENTRA is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients of ZYMFENTRA or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension and serum sickness). HEPATITIS B VIRUS REACTIVATION TNF blockers, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating ZYMFENTRA. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing ZYMFENTRA for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with ZYMFENTRA. Discontinue ZYMFENTRA in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of ZYMFENTRA and monitor patients closely. HEPATOTOXICITY Hepatobiliary disorders, including acute liver failure, jaundice abnormal hepatic function, hepatic steatosis, hepatitis, hepatotoxicity, hyperbilirubinemia and non-alcoholic fatty liver, have been reported in patients receiving infliximab products post-marketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, ZYMFENTRA should be discontinued and a thorough investigation of the abnormality should be undertaken. CONGESTIVE HEART FAILURE Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Some cases had a fatal outcome. In several exploratory trials of other TNF blockers in the treatment of CHF, there were greater proportions of TNF-blocker-treated patients who had CHF exacerbations requiring hospitalization or increased mortality. ZYMFENTRA has not been studied in patients with a history of CHF and ZYMFENTRA should be used with caution in patients with CHF. HEMATOLOGIC REACTION Cases of leukopenia, neutropenia, thrombocytopenia and pancytopenia (some fatal) have been reported. The causal relationship to infliximab-product therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of ZYMFENTRA in patients who develop significant hematologic abnormalities. HYPERSENSITIVITY AND OTHER ADMINISTRATION REACTIONS In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylaxis, hypotension and serum sickness) have been reported following administration of infliximab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA. INJECTION SITE REACTIONS In clinical studies, localized injection-site reactions were reported following administration of ZYMFENTRA. If a clinically significant injection-site reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA. NEUROLOGIC REACTIONS Agents that inhibit TNF have been associated with central nervous system (CNS) manifestation of systemic vasculitis, seizure and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering ZYMFENTRA in patients with these disorders and consider discontinuation if these disorders develop. RISK OF INFECTION WITH CONCURRENT ADMINISTRATION OF OTHER BIOLOGICS PRODUCTS Serious infections and neutropenia have been reported with concurrent use of ZYMFENTRA with other immunosuppressive biological products. The concurrent use of ZYMFENTRA with other immunosuppressive biological products used to treat UC and CD may increase the risk of infection and is not recommended. RISK OF ADDITIVE IMMUNOSUPPRESSIVE EFFECTS FROM PRIOR BIOLOGICAL PRODUCTS Consider the half-life and mode of action of prior biological products to avoid unintended additive immunosuppressive effects when initiating ZYMFENTRA. AUTOIMMUNITY Treatment with TNF blockers may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue ZYMFENTRA treatment if symptoms of a lupus-like syndrome develop. VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS Prior to initiating ZYMFENTRA, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with ZYMFENTRA due to the possibility of clinical infections, including disseminated infections. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to ZYMFENTRA. ADVERSE REACTIONS In clinical trials with ZYMFENTRA, the most common adverse reactions occurring in ≥3% of ZYMFENTRA-treated patients included site reactions, COVID-19, anemia, arthralgia, infection site reaction, increased alanine aminotransferase and abdominal pain for UC, and COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness and leukopenia for CD. Please click for Full U.S. Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About Digestive Disease Week®Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 3-6, 2025. The meeting showcases more than 5,600 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org About Celltrion, Inc.Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us. and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USACelltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo) and OMLYCLO® (omalizumab-igec), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media: LinkedIn. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", "anticipate" the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws.

2025
04
29
U.S. FDA grants interchangeable designation to YUFLYMA® (adalimumab-aaty), Celltrion's biosimilar to Humira® (adalimumab)

YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar, that is now interchangeable [1]Interchangeable designation of YUFLYMA® is supported by positive data from the Phase III interchangeability study in patients with moderate-to-severe plaque psoriasis INCHEON, South Korea, April 14, 2025 -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated YUFLYMA® (adalimumab-aaty), as an interchangeable biosimilar to Humira® (adalimumab). YUFLYMA is an FDA-approved, high-concentration (100mg/mL) and citrate-free formulation of Humira® biosimilar, approved for multiple inflammatory indications.[1] "With this new designation, YUFLYMA is further positioned to help more patients gain access to and afford the therapy they need," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "YUFLYMA has the same dosage form, route of administration, and dosing regimen as the reference product. The pharmacist's ability to substitute the biosimilar directly at the pharmacy without the hassle of a new prescription and without the patient having to learn a new method of administration can be a game changer in increasing patient access to adalimumab." The interchangeable designation was supported by data from the Phase III interchangeability study, which demonstrated similar outcomes in terms of pharmacokinetics, efficacy, safety and immunogenicity in patients with moderately to severely active plaque psoriasis who received reference adalimumab (ADA) continuously and those who alternated between reference ADA and YUFLYMA during the dosing interval of Week 25-27. The result of the interchangeability study was presented at the European Academy of Dermatology & Venereology (EADV) 2024.[2]  FDA-approved interchangeable biosimilars may be substituted for the reference product at the pharmacy without the intervention of the prescribing health care provider, subject to state laws.[3] The high-concentration form of YUFLYMA was FDA-approved in May 2023 and is currently available as 20mg, 40 mg and 80mg solution for injection in a prefilled syringe and in an autoinjector pen. YUFLYMA was introduced into the US commercial market on July 2, 2023. YUFLYMA is available in two pricing options to help provide more affordable options for patients. Adalimumab-aaty, the unbranded version, is priced at an 85% discount to the current wholesale acquisition cost (WAC) list price of Humira (adalimumab), providing economic benefits for patients and overall healthcare system. The branded version is priced at a 5% discount to the current WAC of Humira (adalimumab). Notes to Editors: About YUFLYMA® (CT-P17, biosimilar adalimumab-aaty)[1] YUFLYMA is the world's first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval. YUFLYMA is FDA approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. YUFLYMA has been designated by the FDA as an interchangeable biosimilar in a prefilled syringe. YUFLYMA is a recombinant fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody. YUFLYMA is available in 20mg/0.2mL, 40mg/0.4mL and 80mg/0.8mL. IMPORTANT SAFETY INFORMATION[1]This important safety information also applies to YUFLYMA® (adalimumab-aaty) SERIOUS INFECTIONS Patients treated with adalimumab-aaty are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before adalimumab-aaty use and during therapy. Initiate treatment for latent TB prior to adalimumab-aaty use.Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with adalimumab-aaty prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with adalimumab-aaty, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Treatment with adalimumab-aaty should not be initiated in patients with an active infection, including localized infections.Patients over 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with adalimumab-aaty, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy.Drug interactions with biologic products: In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of adalimumab-aaty with abatacept or anakinra is not recommended in patients with RA. A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of adalimumab-aaty and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS. Concomitant administration of adalimumab-aaty with other biologic DMARDs (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to the use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. Consider the risks and benefits of TNF blocker treatment including adalimumab-aaty prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC), or when considering continuing a TNF blocker in patients who develop a malignancy.In controlled portions of clinical trials of some adalimumab products, more cases of malignancies have been observed compared to control-treated adult patients.Non-melanoma skin cancer (NMSC) was reported during clinical trials for patients treated with adalimumab products. During the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, PS, HS and UV, the rate (95% confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100 patient-years among adalimumab-treated patients and 0.2 (0.10, 0.59) per 100 patient-years among control-treated patients. Examine all patients, particularly those with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment, for the presence of NMSC prior to and during treatment with adalimumab-aaty.In clinical trials of some adalimumab products, there was an approximately threefold higher rate of lymphoma than expected in the general U.S. population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to severalfold) than the general population for the development of lymphoma, even in the absence of TNF blockers.Postmarketing cases of acute and chronic leukemia were reported with the use of a TNF blocker in RA and other indications. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving adalimumab were lymphomas; other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. HYPERSENSITIVITY Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of adalimumab-aaty and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including adalimumab-aaty, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV and closely monitor such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy.In patients who develop HBV reactivation, stop adalimumab-aaty and initiate effective antiviral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of adalimumab-aaty therapy in this situation and monitor patients closely. NEUROLOGIC REACTIONS Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.Exercise caution in considering the use of adalimumab-aaty in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of adalimumab-aaty should be considered if any of these disorders develop.There is a known association between intermediate uveitis and central demyelinating disorders. HEMATOLOGIC REACTIONS Rare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents.Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with adalimumab products.Consider discontinuation of adalimumab-aaty therapy in patients with confirmed significant hematologic abnormalities. HEART FAILURE Cases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products.Exercise caution when using adalimumab-aaty in patients who have heart failure and monitor them carefully. AUTOIMMUNITY Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with adalimumab-aaty, discontinue treatment. IMMUNIZATIONS Patients on adalimumab-aaty may receive concurrent vaccinations, except for live vaccines.It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating adalimumab-aaty therapy.No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products.The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. ADVERSE REACTIONS The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. INDICATIONS Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RAJuvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and olderPsoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsAAnkylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active ASCrohn's Disease (CD): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and olderUlcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adultsLimitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockersPlaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriateHidradenitis Suppurativa (HS): treatment of adult patients with moderate to severe hidradenitis suppurativaUveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients For Yuflyma (adalimumab-aaty): Please click for Full U.S. Prescribing Information. For adalimumab-aaty: Please see Full U.S. Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About Celltrion, Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo) and OMLYCLO® (omalizumab-igec), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media: LinkedIn. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", "anticipate" the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements.Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. Trademarks Humira is a registered trademark of AbbVie. YUFLYMA® is a registered trademark of Celltrion, Inc., used under license. References [1] YUFLYMA US prescribing information (2023) [2] Lebwohl M et al., Pharmacokinetics, Efficacy and Safety after Multiple Switches from Reference Adalimumab to Adalimumab Biosimilar (CT-P17) in comparison with the Maintenance Group (Reference Adalimumab) in Patients with Moderate-toSevere Plaque Psoriasis: Week 27 Results from the Phase III Interchangeability Study. [EADV 2024, Poster number P0931]. Available at: https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.eadv/abstracts_congress_2024/41489.pdf [3] 9 Things to Know About Biosimilars and Interchangeable Biosimilars. Available at : https://www.fda.gov/drugs/things-know-about/9-things-know-about-biosimilars-and-interchangeable-biosimilars

2025
04
15
Celltrion's STEQEYMA® (ustekinumab-stba), now added to the Costco Member Prescription Program

STEQEYMA® (ustekinumab-stba) is Celltrion's biosimilar to STELARA® (ustekinumab), which was launched on March 12, 2025Celltrion's adalimumab-aaty was previously added to the Costco Member Prescription Program in August 2024 JERSEY CITY, N.J., March 27, 2025 - Celltrion, Inc., today announced that STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab) has been added to the Costco Member Prescription Program. "We're focused on improving affordability and access to a widely used, high-cost treatment for a variety of inflammatory conditions," said Francine Galante, Vice President of Market Access at Celltrion USA. "The addition of STEQEYMA to the Costco Member Prescription Program together with adalimumab-aaty will help us deliver our commitment to lowering financial barriers and improving access to critical treatments." STEQEYMA is available in both subcutaneous injection and intravenous infusion and is indicated for the treatment of plaque psoriasis (PsO) and psoriatic arthritis (PsA) in adult and pediatric patients, as well as Crohn's disease (CD) and ulcerative colitis (UC) in adult patients. The Costco Member Prescription Program is a prescription drug discount card program offered by Costco Health Solutions that provides eligible Costco members and their eligible dependents the ability to obtain lower prices on STEQEYMA and other participating drugs at Costco Specialty Pharmacies and at participating pharmacies.  "By partnering with Costco Health Solutions once again, we are able to help even more Americans lower the price of their prescriptions, given the fact that Stelara ranks as one of the most expensive prescription drugs on the market," said Tom Nusbickel, Chief Commercial Officer at Celltrion USA. STEQEYMA will be available in the U.S. from Costco Specialty Pharmacies on April 1st, 2025, for self-funded employer plans and Costco members who are uninsured and want to pay cash for their STEQEYMA prescription or who have been denied coverage by their insurers. Notes to Editors: About STEQEYMA® (ustekinumab-stba)STEQEYMA®, formerly known as CT-P43, is a human IL-12 and -23 antagonist indicated for multiple immune-mediated diseases. It encompasses all indications approved for the STELARA® reference product, including psoriasis (PsO), psoriatic arthritis (PsA), Crohn's disease (CD), ulcerative colitis (UC) in adults, and PsO and PsA in pediatric patients 6 years of age and older. STEQEYMA is available in both subcutaneous and intravenous formulations. The subcutaneous injection comes in two strengths: 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial. INDICATIONSSTEQEYMA® (ustekinumab-stba) is indicated for the treatment of:Plaque Psoriasis (PsO) in adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.Psoriatic Arthritis (PsA) in adults and pediatric patients 6 years of age and older with active psoriatic arthritis.Crohn's Disease (CD) in adult patients with moderately to severely active Crohn's disease.Ulcerative Colitis (UC) in adult patients with moderately to severely active ulcerative colitis. IMPORTANT SAFETY INFORMATIONSTEQEYMA® is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STEQEYMA.Serious infections have occurred. Avoid starting STEQEYMA during any clinically important active infection. If a serious or clinically significant infection develops, discontinue STEQEYMA until the infection resolves.Serious infections from mycobacteria, salmonella, and BCG vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances.Evaluate patients for TB prior to starting STEQEYMA. Initiate treatment of latent TB before administering STEQEYMA.Ustekinumab products may increase risk of malignancy. The safety of ustekinumab products in patients with a history of or a known malignancy has not been evaluated. Monitor all patients receiving STEQEYMA for signs of malignancies.If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STEQEYMA.If Posterior Reversible Encephalopathy Syndrome (PRES) is suspected, treat promptly and discontinue STEQEYMA.Avoid use of live vaccines in patients during treatment with STEQEYMA. Non-live vaccinations received during STEQEYMA treatment may not elicit enough immune response to prevent disease.If diagnosis of noninfectious pneumonia is confirmed, discontinue STEQEYMA and institute appropriate treatment.The most common adverse reactions (≥3%) reported in patients receiving ustekinumab were:Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, and fatigue.CD: vomiting, nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis.UC: nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea. For more information, see Full Prescribing Information. About CelltrionCelltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us. and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USACelltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has ten biosimilars approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (Ustekinumab-stba) STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), and OMLYCLO® (omalizumab-igec) as well as a novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media: LinkedIn. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements.Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. TrademarksSTELARA® is a registered trademark of Johnson & Johnson.STEQEYMA® is a registered trademark of Celltrion, Inc., used under license.

2025
03
27
STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), now available in the United States

  STEQEYMA®, one of the first-wave biosimilars to STELARA®, is now available in the U.S. Approved for the same indications as the reference product, STEQEYMA will be priced with a wholesale acquisition cost (WAC) list price at an 85% discount to the current WAC list price of STELARA to help improve patient access to high-quality biologic treatments[1] With the launch of STEQEYMA, Celltrion expands its immunology portfolio beyond tumor necrosis factor (TNF)-alpha inhibitors, to include interleukin (IL)-12 and IL-23 inhibitors, broadening treatment options for multiple immune-mediated diseases Celltrion has nine biosimilars and five immunology biologics granted marketing authorization in the U.S. JERSEY CITY, N.J., March 12, 2025 - Celltrion today announced the U.S. launch of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), following approval by the U.S. Food and Drug Administration (FDA) in December 2024. STEQEYMA is approved for the same indications as STELARA, providing consistency in treatment for patients and healthcare providers.[1] STEQEYMA is indicated for the treatment of plaque psoriasis (PsO) and psoriatic arthritis (PsA) in adult and pediatric patients, as well as Crohn's disease (CD) and ulcerative colitis (UC) in adult patients. It is available in both subcutaneous injection and intravenous infusion.[1] "Chronic inflammatory diseases such as plaque psoriasis and psoriatic arthritis place significant burden on patients," said Mark G. Lebwohl*, MD, Icahn School of Medicine at Mount Sinai, New York. "Biosimilars increase access to essential therapies, while maintaining the same high standards as the reference product. The availability of STEQEYMA provides patients and healthcare providers a cost-effective alternative to manage chronic inflammatory diseases." STEQEYMA will be priced with a WAC list price at an 85% discount to the current WAC list price of STELARA to help improve patient access to high-quality biologic treatments. The FDA approval of STEQEYMA was based on the totality of evidence, including the results from a Phase III study in adults with moderate to severe plaque psoriasis, in which the primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. The clinical results demonstrated that STEQEYMA and its reference product, ustekinumab, are highly similar, and have no clinically meaningful differences in terms of safety and efficacy. [2],[3] "The introduction of STEQEYMA in the U.S., as one of the first-wave biosimilars to STELARA, marks an important step in our ongoing efforts to expand patient access to high-quality biologic treatments," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "With this launch, we are expanding our immunology portfolio beyond TNF-alpha to include IL-12/23 inhibitors, offering more options for multiple immune-mediated diseases. To further enhance accessibility, Celltrion is actively collaborating with key pharmacy benefit managers to secure broader formulary coverage for STEQEYMA." STEQEYMA is supported by Celltrion's comprehensive patient and practice support programs, designed to assist patients throughout their treatment journey. Celltrion offers a suite of resources, including Celltrion CONNECT® Patient Support Program and Celltrion CARES™ Co-pay Assistance Program, benefits verification, prior authorization assistance, and co-pay assistance. Eligible patients with private or commercial insurance may pay as little as $0 out of pocket per dose. Patients who are uninsured may be eligible to receive STEQEYMA through the Celltrion CONNECT® Patient Assistance Program (PAP). Additionally, nurses will be available to answer patient questions and provide injection support. Visit www.CelltrionConnect.com to learn more. Celltrion has nine biosimilars approved by the FDA, demonstrating its established leadership in the biosimilar development space and its commitment to advancing high-quality treatments. STEQEYMA has also received approval in key global markets, including the European Union, Canada and Australia.  Notes to Editors:*Dr. Mark Lebwohl is a paid consultant for Celltrion. About STEQEYMA® (ustekinumab-stba)STEQEYMA®, formerly known as CT-P43, is a human IL-12 and -23 antagonist indicated for multiple immune-mediated diseases. It encompasses all indications approved for the STELARA® reference product, including psoriasis (PsO), psoriatic arthritis (PsA), Crohn's disease (CD), ulcerative colitis (UC) in adults, and PsO and PsA in pediatric patients 6 years of age and older. STEQEYMA is available in both subcutaneous and intravenous formulations. The subcutaneous injection comes in two strengths: 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial. INDICATIONSSTEQEYMA® (ustekinumab-stba) is indicated for the treatment of: Plaque Psoriasis (PsO) in adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Psoriatic Arthritis (PsA) in adults and pediatric patients 6 years of age and older with active psoriatic arthritis. Crohn's Disease (CD) in adult patients with moderately to severely active Crohn's disease. Ulcerative Colitis (UC) in adult patients with moderately to severely active ulcerative colitis. IMPORTANT SAFETY INFORMATION STEQEYMA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STEQEYMA.  Serious infections have occurred. Avoid starting STEQEYMA during any clinically important active infection. If a serious or clinically significant infection develop, discontinue STEQEYMA until the infection resolves. Serious infections from mycobacteria, salmonella, and BCG vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances. Evaluate patients for TB prior to starting STEQEYMA. Initiate treatment of latent TB before administering STEQEYMA. Ustekinumab products may increase risk of malignancy. The safety of ustekinumab products in patients with a history of or a known malignancy has not been evaluated. Monitor all patients receiving STEQEYMA for signs of malignancies. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STEQEYMA. If Posterior Reversible Encephalopathy Syndrome (PRES) is suspected, treat promptly, and discontinue STEQEYMA. Avoid use of live vaccines in patients during treatment with STEQEYMA. Non-live vaccinations received during STEQEYMA treatment may not elicit enough immune response to prevent disease. If diagnosis of noninfectious pneumonia is confirmed, discontinue STEQEYMA and institute appropriate treatment. The most common adverse reactions (≥3%) reported in patients receiving ustekinumab were: Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, and fatigue. CD: vomiting, nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. UC: nasopharyngitis, nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea. For more information, see Full Prescribing Information. About CelltrionCelltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us. and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USACelltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has nine biosimilars approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), STEQEYMA® (ustekinumab-stba), AVTOZMA® (tocilizumab-anoh), OSENVELT®/ STOBOCLO® (denosumab-bmwo), and OMLYCLO® (omalizumab-igec), as well as a novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media: LinkedIn.FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares," "hopes to," "upcoming," "plans to," "aims to," "to be launched," "is preparing," "once gained," "could," "with the aim of," "may," "once identified," "will," "working towards," "is due," "become available," "has potential to," the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements.Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. TrademarksSTELARA® is a registered trademark of Johnson & Johnson.STEQEYMA® is a registered trademark of Celltrion, Inc., used under license. References[1] STEQEYMA U.S. prescribing information (2024)[2] Papp KA et al., Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III study. BioDrugs. 2023; Online ahead of print. Available at: https://link.springer.com/article/10.1007/s40259-023-00630-5#article-info [Last accessed February 2025][3] Papp K et al., Efficacy and Safety after Switch from Reference Ustekinumab to Ustekinumab Biosimilar (CT-P43) in comparison with the Maintenance Group (CTP43 or Reference Ustekinumab) in Patients with Moderate-to-Severe Plaque Psoriasis: 1-Year Result. [EADV 2023, Abstract #4035]. Available at: https://eadv.org/wp-content/uploads/scientific-abstracts/EADV-congress-2023/Biologics-immunotherapy-targeted-therapy.pdf [Last accessed February 2025]

2025
03
13
[Letter to Shareholders – Notice Regarding Bonus Issue of Shares]

Dear Shareholders, On Monday, May 26, Celltrion announced its plan to conduct a bonus issue of shares aimed at enhancing shareholder value. We would like to provide the following information regarding this matter:  ■ Key Details of the Bonus Issue The company has resolved to issue 0.04 new common shares for each existing share. The scheduled listing date for the new shares is July 25, 2025, and the record date (closure of shareholder registry) is June 10, 2025. The total number of new shares to be issued is 8,494,384. This issuance amount has been determined by taking into account the number of treasury shares previously repurchased by the company, thereby minimizing the burden on circulating shares. Compared to the cancellation of treasury shares, a bonus issue allows for the sharing of potential value gains with shareholders when the new shares are listed. As noted, the new shares are scheduled to be listed on July 25, and around that time, the company plans to announce its Q2 provisional earnings. Through this bonus issue, shareholders can expect an approximately 4% stock dividend effect. This decision was made in light of recent excessive undervaluation of our stock price due to external supply factors—such as the resumption of short selling and tariff-related issues—despite fundamental improvements in the company. It reflects our confidence in the company’s value and our commitment to responsible shareholder value enhancement.  ■ Ongoing Commitment to Responsible Management and Shareholder Value Enhancement The company is continuing its responsible management practices to stabilize the stock price and encourage long-term investment. This includes activities such as share buybacks and cancellations, CEO stock purchases, and the "Value-Up Program" announced in March. With continued annual revenue growth exceeding 30%, this year we anticipate more than 40% growth year-over-year, driven by the launch of four high-margin biosimilar products. However, despite these fundamental strengths, the stock remains significantly undervalued due to external factors like the resumption of short selling and tariff issues. This bonus issue aims to restore market confidence and enhance shareholder value. Going forward, we will actively respond to market distortions and work toward mid- to long-term performance improvement. We also remain committed to our principle of returning at least 30% of EBITDA-CAPEX (earnings before interest, tax, depreciation, and amortization minus capital expenditures) to shareholders as part of our responsible management policy.  We sincerely appreciate your continued trust and support in Celltrion. Thank you.   ※ Tax Information Regarding the Bonus Issue This bonus issue will be conducted using tax-exempt capital, so the newly issued shares themselves will not be taxed as dividend income. However, since treasury shares are excluded from the allocation, all shareholders will see an increase in ownership ratio post-issue, which may be subject to deemed dividend taxation under the relevant tax laws. For shareholders holding fewer than 3,945 shares before the bonus issue, the deemed dividend from the ownership ratio increase is estimated to fall below the minimum tax threshold (KRW 1,000), and therefore will not be subject to separate income tax. However, if total financial income (including dividends and interest) exceeds KRW 20 million in 2025, the deemed dividend from this bonus issue will be added to the total taxable amount and may incur additional tax. (No additional tax applies if total financial income is below KRW 20 million.)  ※ Celltrion resolved to conduct a stock bonus issue through a board resolution on May 26, 2025. In accordance with Article 176-2, Paragraph 2, Subparagraph 3 of the Enforcement Decree of the Financial Investment Services and Capital Markets Act, the company will not acquire any treasury shares between the date of the board resolution and the record date for the allocation of new shares (June 10, 2025). Accordingly, reflecting changes in the treasury stock acquisition plan, the number of new shares to be issued as previously disclosed on May 26 has been corrected from 8,477,626 shares to 8,494,384 shares (as disclosed on May 28).

2025
05
26
Letter to Shareholders [Explanation and Company Position Regarding the U.S. Government's Follow-Up Measures on the Drug Price Reduction Executive Order Issued by the Trump Administration]

Dear Shareholders,On May 20, 2025 (local time), the U.S. Department of Health and Human Services (HHS) announced follow-up measures regarding the executive order on drug price reduction that was publicly released on May 12. We would like to share a summary of the announcement and Celltrion’s position as follows:  1. Summary of the Announcement• The announcement outlines the pricing targets introduced in the executive order titled “Ensuring American Patients Access to Prescription Drugs at Most-Favored-Nation Prices” issued on May 12.• HHS has set specific most-favored-nation (MFN) level price targets that pharmaceutical companies must follow to comply with the executive order.• For high-cost prescription drugs, the MFN price benchmark will be based on the lowest price available in OECD countries whose gross national income is at least 60% of that of the U.S.• The U.S. government plans to announce agreements with pharmaceutical companies in the coming weeks to ensure Americans do not pay more than patients in other countries.• The policy is expected to significantly lower U.S. drug prices, which are currently 3 to 5 times higher than those overseas, by aligning them with MFN price levels.• The government expects pharmaceutical companies to comply with the price reductions; otherwise, federal enforcement measures will be implemented. 2. Impact on Our Company• As explained during the Celltrion Online Conference held on May 15, the announced measures are aimed at high-cost drugs that burden American patients. Since Celltrion’s biosimilar products are already priced competitively and contribute to lowering drug prices through market competition, they are not the primary targets of this policy. Thus, the impact on our products is expected to be limited.• Should the MFN pricing policy lead to lower prices for high-cost drugs, it may shift the prescribing environment from originator-biased formularies to one favoring direct competition with biosimilars. This shift could provide an opportunity for broader use of biosimilar products.• In the case of Zymfentra, it has only been approved as a novel drug in the U.S., while it is marketed as a biosimilar in other countries. Therefore, it is not expected to fall under the scope of the MFN pricing reference.• Taken together, the executive order and related policy changes—such as promoting biosimilar use and improving intermediary distribution structures—indicate a favorable policy stance for Celltrion, and we anticipate these developments will create positive business opportunities.  The measures announced are consistent with what Celltrion Group Chairman Seo Jung-Jin stated during the May 15 meeting. As the pricing policy is proceeding within the scope we had anticipated, we believe it will have a favorable impact on Celltrion as a biosimilar manufacturer.We are providing this explanation to reassure our shareholders and affirm that Celltrion remains committed to responding proactively to global healthcare policy shifts—including those in the U.S.—and leveraging these developments to drive performance and growth.Thank you.  

2025
05
21
[Letter to Our Shareholders] Notice of an Upcoming Shareholder Meeting and Initiatives to Enhance Shareholder Value

Dear Valued Shareholders,On Thursday, May 15, 2025, Celltrion Group Chairman Jung Jin Seo held an online meeting with domestic and international journalists, analysts, and institutional investors. During the session, he personally addressed the company’s strategic response to rapid changes in the global biopharmaceutical market, including recent shifts in U.S. pharmaceutical policy, and shared the company’s outlook for 2025. This event served as a timely opportunity to reduce market uncertainties. Celltrion remains firmly committed to its core principles and continuous efforts to enhance shareholder value. Our future plans in this regard are outlined below:■ Shareholder Meeting Scheduled for Late May We will hold a separate shareholder meeting at the end of May, presided over by the CEO. This meeting reflects our sincere intention to communicate transparently with our shareholders. Preparations are currently underway, and we will promptly provide further details once finalized. ■ Ongoing Share Buybacks and Executive Share Purchases So far this year, we have acquired treasury shares worth KRW 450 billion to help stabilize the market. We will continue monitoring the market and consider additional buybacks if necessary. In addition, key executives across Celltrion Group, including Celltrion Holdings, plan to purchase company shares, and employee participation through the Employee Stock Ownership Plan (ESOP) is also set to proceed. These initiatives reflect the voluntary commitment of our organization to participate in market stabilization efforts. If needed, additional executive share purchases will also be considered. ■ Strengthened Global Sales Efforts Personnel across our global subsidiaries and the Global Sales Business Group remain fully dedicated to driving operational excellence and delivering improved performance across key markets. The company will continue to extend its full support to ensure these initiatives contribute meaningfully to our objectives. Furthermore, our senior leadership will visit overseas markets in person to oversee frontline sales activities and reinforce our commitment to sales growth. We remain dedicated to improving our business performance and stabilizing our stock price. Lastly, we would like to make one request to our valued shareholders. Recently, there has been a sharp increase in stock lending (securities lending) transactions. Excessive lending can be used for short selling, which may hinder our efforts to stabilize the share price and delay the positive outcomes we and our shareholders are striving for. We therefore respectfully ask shareholders who have lent out their shares to consider recalling them. If you receive requests for stock lending, we urge you to consider them carefully before proceeding. Your support is vital in helping Celltrion pursue long-term growth and enhance corporate value. Thank you once again for your continued trust and support.

2025
05
18
[Letter to Our Esteemed Shareholders] Company Response Strategy Regarding the Trump Administration's Executive Order on Most-Favored-Nation Drug Pricing

Dear Valued Shareholders,On May 12, 2025 (local time), US President Donald J. Trump signed an executive order mandating that prescription drug prices in the United States be aligned with those of other countries. In light of the heightened interest and inquiries from our shareholders, we would like to share our analysis and response strategy below.  1. Key Points of the U.S. Executive Order and Changes in the Market Landscape• The executive order aims to reduce the prices Americans pay for prescription drugs to levels comparable with those in other countries.• To achieve this, ▲ the Secretary of Health and Human Services (HHS) is tasked with implementing a program that allows U.S. patients to directly purchase medications from pharmaceutical companies at the Most-Favored-Nation (MFN) price, and ▲ the Secretary is also required to communicate target MFN prices for U.S. patients to pharmaceutical companies within 30 days.• The core focus of the announcement is ultimately on ▲ reforming middlemen structures (e.g., PBMs) and ▲ reducing prices for high-cost drugs. This is expected to present positive opportunities for our U.S. operations.The significance of the executive order and its impact on Celltrion are as follows: 2. Impact on Celltrion and Business Opportunities• For Celltrion, whose business structure is centered on biosimilars, the executive order is expected to create a more favorable business environment in the following ways. 2-1. Opportunities from the Streamlining of Intermediary Distribution Structures• One of the key pillars of the announced executive order is the reform of intermediary distribution structures (e.g., PBMs), which is anticipated to present positive opportunities for our U.S. operations.• The distribution dominance established by high-margin pharmaceutical companies relying on branded products is expected to weaken. This could create opportunities for biosimilar companies operating in a competitive landscape to expand their market presence.• In particular, biosimilar manufacturers will have the opportunity to negotiate drug prices directly with the government, rather than through middlemen such as PBMs, which is expected to create benefits for both the government and manufacturers. 2-2. Opportunities for Accelerating Biosimilar Adoption with the Reduction in High-Cost Drug Prices• One of the key aspects of the executive order is the reduction of high-cost drug prices, which is expected to have a positive impact on our U.S. operations.• Currently, under the U.S. insurance and PBM system, high-cost branded drugs are first prioritized on formularies, followed by limited competition among biosimilar products, with only 2-3 additional products being listed.• Due to the issue surrounding rebates to middlemen, biosimilar prices are set at levels similar to those of originator drugs in hospital prescriptions, which prevents tangible benefits for patients. This has significantly limited the market expansion of biosimilars in the U.S. compared to Europe.• As a result, the biosimilar prices we currently supply in the U.S. are not as competitive as those in Europe.• However, with the implementation of the executive order and improvements in the intermediary distribution structure, the actual prescription prices of biosimilars will be reduced, and the benefits to both the government and patients will be clear. This will accelerate the expansion of biosimilar prescriptions to levels similar to those in Europe. 2-3. Opportunities from Parallel Imports and Portfolio Expansion• If parallel imports are activated as part of the executive order to supply pharmaceuticals at Most-Favored-Nation (MFN) prices, Celltrion will have the opportunity to introduce products that were previously not launched in the U.S.• With our direct sales network in the U.S. and extensive experience in the European market, we can expect to accelerate sales by expanding our product portfolio and leveraging marketing synergies.After thoroughly reviewing the executive order, we believe that it will work in favor of biosimilar manufacturers, and specifically, for companies like Celltrion, which directly sells biosimilars in the U.S., it presents another significant opportunity. We will continue to monitor the specific implementation procedures and policy direction from the U.S. government, adapting our strategies flexibly and proactively in response to any changes in the situation. Through this approach, we are committed to rewarding the ongoing trust and support of our shareholders by responding swiftly to global healthcare policy changes, particularly in the U.S., and achieving tangible results. Thank you once again for your unwavering confidence in us.

2025
05
13